CONTENTS

7 OVERVIEW

7 Latest key takeaways

8 DISEASE BACKGROUND

8 Definition

8 Patient segmentation

9 TREATMENT

9 ACR treatment guidelines

11 EULAR treatment guidelines

14 EPIDEMIOLOGY

14 Prevalence methodology

17 MARKETED DRUGS

27 PIPELINE DRUGS

38 KEY REGULATORY EVENTS

38 Pfizer Has Eyes On EU Rituximab Market Following EC Approval

38 Mylan And Lupin Get EU Etanercept Nod

38 Celltrion Eyes ‘Competitive Edge’ With Adalimumab Filing

38 Celltrion Launches Remsima SC In UK

39 Pfizer’s Ruxience Rituximab Biosimilar Gets CHMP Nod

39 Pfizer Will Not Launch EU Adalimumab

39 EU Approvals: Rinvoq Cleared For RA

39 CHMP Positive On Pfizer’s Adalimumab

40 Amgen Gets US Infliximab Nod

40 Pfizer’s FDA-Approved Adalimumab Faces Four-Year Wait

40 Celltrion Pushes ‘Biobetters’ Concept With Remsima SC

41 Bio-Thera Solutions Has China’s First Adalimumab Biosimilar

41 EMA Recommends Caution For Pfizer’s Xeljanz

41 Celltrion Will Sell World’s First Subcutaneous Infliximab Directly In Europe

41 AbbVie’s Post-Humira Strategy Continues Taking Shape With Rinvoq Approval

42 Europe’s Biotechs Gathering Steam With Filgotinib Filing

42 Samsung Bioepis Gets US Adalimumab Nod

42 Nichi-Iko Looks To File For Interchangeable Infliximab In US Next Year

43 PROBABILITY OF SUCCESS

44 LICENSING AND ASSET ACQUISITION DEALS

44 Beximco And Mylan Strike Biosimilars Deal

44 Mundipharma Will Sell Samsung Bioepis’ Biosimilars In Taiwan, Hong Kong

44 Deals Shaping The Medical Industry, January 2020

44 CC-Pharming And iBio Expand Chinese Rituximab Venture
44 $5bn Galapagos Deal Won’t Be Last For Gilead, Says O’Day

46 CLINICAL TRIAL LANDSCAPE

48 Celltrion Begins US Phase III For Infliximab SC, Aims For 2022 Launch

49 Start-Up Spotlight: SetPoint Develops Vagus Nerve Stimulation To Treat Crohn’s Disease And Rheumatoid Arthritis

49 Interview: Abivax Equipped To Enter Anti-Inflammatory Market

49 GSK’s Otilimab Goes Head-To-Head To Crack Rheumatoid Arthritis

49 Gilead To File Filgotinib For RA in 2019, Earlier Than Forecast

50 Celltrion Reports Positive Rheumatoid Arthritis Data From Subcutaneous Infliximab

50 AbbVie Ups The Ante For Upadacitinib At EULAR

51 DRUG ASSESSMENT MODEL

53 MARKET DYNAMICS

54 FUTURE TRENDS

54 Brands will face headwinds as the RA market is penetrated by more biosimilars

54 Spearheaded by Humira and Enbrel, the anti-TNF class will remain dominant, despite pressure from biosimilars

54 Expansion of the JAK inhibitor class will be dampened by the entry of generic tofacitinib and safety concerns

56 CONSENSUS FORECASTS

61 RECENT EVENTS AND ANALYST OPINION

61 Multiple Drugs for Rheumatoid Arthritis (June 25, 2019)

61 Filgotinib for Rheumatoid Arthritis (March 28, 2019)

63 Filgotinib for Rheumatoid Arthritis (March 28, 2019)

65 Xeljanz / Xeljanz XR for Rheumatoid Arthritis (February 19, 2019)

66 Biosimilar Rituximab (Amgen) for Rheumatoid Arthritis (January 24, 2019)

67 AVT-02 for Rheumatoid Arthritis (November 19, 2018)

68 Otilimab for Rheumatoid Arthritis (October 23, 2018)

70 Hyrimoz for Rheumatoid Arthritis (October 22, 2018)

71 Otilimab for Rheumatoid Arthritis (October 21, 2018)

74 KEY UPCOMING EVENTS

75 KEY OPINION LEADER INSIGHTS

75 Therapies are clinically comparable

75 Pricing and insurance coverage drive prescribing

76 UNMET NEEDS

76 There is critical unmet need for effective drugs that achieve remission

76 Unmet need exists for targeted treatments applied with a stratified medicine

76 With RA patients being treated with costly specialty drugs, more affordable treatments are needed

77 Better tolerated, safer drugs are desired

78 BIBLIOGRAPHY

79 Prescription information

81 APPENDIX

LIST OF FIGURES
16 Figure 1: Trends in prevalent cases of rheumatoid arthritis, 2018–27

27 Figure 2: Overview of pipeline drugs for rheumatoid arthritis in the US

27 Figure 3: Pipeline drugs for rheumatoid arthritis, by company

28 Figure 4: Pipeline drugs for rheumatoid arthritis, by drug type

28 Figure 5: Pipeline drugs for rheumatoid arthritis, by classification

43 Figure 6: Probability of success in the rheumatoid arthritis pipeline

46 Figure 7: Clinical trials in rheumatoid arthritis

46 Figure 8: Top 10 drugs for clinical trials in rheumatoid arthritis

47 Figure 9: Top 10 companies for clinical trials in rheumatoid arthritis

47 Figure 10: Trial locations in rheumatoid arthritis

48 Figure 11: Rheumatoid arthritis trials status

48 Figure 12: Rheumatoid arthritis trials sponsors, by phase

51 Figure 13: Datamonitor Healthcare’s drug assessment summary for rheumatoid arthritis

53 Figure 14: Market dynamics in rheumatoid arthritis

54 Figure 15: Future trends in rheumatoid arthritis

63 Figure 16: Filgotinib for Rheumatoid Arthritis (March 28, 2019): Phase III – FINCH 3

65 Figure 17: Filgotinib for Rheumatoid Arthritis (March 28, 2019): Phase III - FINCH 1

70 Figure 18: Otilimab for Rheumatoid Arthritis (October 23, 2018): Phase IIa - 205180

73 Figure 19: Otilimab for Rheumatoid Arthritis (October 21, 2018): Phase IIb - BAROQUE (w/Methotrexate)

74 Figure 20: Key upcoming events in rheumatoid arthritis

LIST OF TABLES
9 Table 1: 2015 ACR recommendations for patients with symptomatic early RA

10 Table 2: 2015 ACR recommendations for patients with established RA

12 Table 3: 2016 EULAR recommendations for the management of RA

15 Table 4: Prevalent cases of rheumatoid arthritis, 2018–27

18 Table 5: Marketed drugs for rheumatoid arthritis

29 Table 6: Pipeline drugs for rheumatoid arthritis in the US

57 Table 7: Historical global sales, by drug ($m), 2014–18

59 Table 8: Forecasted global sales, by drug ($m), 2020-24

61 Table 9: Multiple Drugs for Rheumatoid Arthritis (June 25, 2019)

62 Table 10: Filgotinib for Rheumatoid Arthritis (March 28, 2019)

64 Table 11: Filgotinib for Rheumatoid Arthritis (March 28, 2019)

66 Table 12: Xeljanz / Xeljanz XR for Rheumatoid Arthritis (February 19, 2019)

67 Table 13: Biosimilar Rituximab (Amgen) for Rheumatoid Arthritis (January 24, 2019)

68 Table 14: AVT-02 for Rheumatoid Arthritis (November 19, 2018)

69 Table 15: Otilimab for Rheumatoid Arthritis (October 23, 2018)

71 Table 16: Hyrimoz for Rheumatoid Arthritis (October 22, 2018)
72 Table 17: Otilimab for Rheumatoid Arthritis (October 21, 2018)